Isavuconazonium Pregnancy and Breastfeeding Warnings

Isavuconazonium Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:-Based on animal data, this drug may increase the risk of adverse developmental outcomes above background risk.-Women who become pregnant while taking this drug should contact their physician.

Animal studies have revealed evidence of perinatal mortality and teratogenicity; dose-related increases in the incidences of rudimentary cervical ribs, zygomatic arch fusion, and supernumerary ribs/rudimentary supernumerary ribs observed. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.